Company Overview - The company is listed on the Hong Kong Stock Exchange under the ticker 9688 and on NASDAQ as ZLAB[1]. Financial Performance - The financial summary indicates significant growth in revenue, with a year-over-year increase of 25%[3]. - The company projects a revenue guidance of $200 million for the next fiscal year, representing a 20% growth[3]. - The top five customers accounted for approximately 32.4% and 35.0% of the total product revenue in 2024 and 2023, respectively[94]. - The company has incurred losses since its inception and expects to continue doing so for several quarters unless it generates sufficient revenue from approved commercialized products[119]. - The company has received a total of $466.5 million from its Hong Kong subsidiary for operations in mainland China from 2014 to 2024[114]. User Engagement - User data shows an increase in active users by 15% compared to the previous year, reaching a total of 1.5 million users[3]. Product Development and Pipeline - New product development includes a pipeline of three innovative therapies expected to enter clinical trials in Q2 2024[3]. - The company is focused on expanding and strengthening its pipeline through internal drug discovery efforts and business development activities[18]. - The company has a diverse pipeline of potential first-in-class and best-in-class products, with several assets in late-stage development and others in clinical and preclinical stages[36]. - The company aims to add at least one new IND application each year to its pipeline[38]. - The company is evaluating additional potential indications for its commercialized products[20]. Market Expansion - The company plans to expand its market presence in Europe, targeting a 30% increase in market share by 2025[3]. - The company has established a strong commercialization infrastructure to support the sales of its products across major medical centers in Greater China[19]. Regulatory Compliance and Risks - Risk factors include potential regulatory changes in China that could impact operations and market access[11]. - The company emphasizes the importance of maintaining compliance with international laws to mitigate legal risks[11]. - The company operates under complex regulations for drug development and approval in China, requiring significant resources and compliance efforts[74]. - The company must comply with various regulations regarding the procurement, storage, sale, and transportation of drugs in mainland China[79]. Strategic Partnerships and Collaborations - The company has strategic partnerships with leading global biopharmaceutical companies to enhance its product pipeline[14]. - The company has established various licensing and collaboration agreements with third parties to develop and commercialize its products and candidates, involving milestone payments and royalties based on annual sales[56]. Production and Quality Control - The company has two production facilities in Suzhou, China, supporting commercialization and clinical production for several products and candidates, including a drug named Zele[96]. - The company has implemented a strict quality control system in compliance with national regulations, monitoring operations throughout the production process from raw material inspection to product delivery[102]. Financial Strategy and Investment - The company’s investment strategy aims to minimize risk by matching the maturity of the investment portfolio with expected operational cash needs[113]. - The company may seek to raise additional capital through equity sales, debt financing, or strategic partnerships, which could dilute shareholder equity[168]. Challenges and Competition - The biopharmaceutical industry is highly competitive, with many companies vying for approval of products targeting the same therapeutic areas, which may have more financial and R&D resources than the company[103]. - The company faces significant competition from major pharmaceutical, biotech, and medical device companies, which may adversely affect its financial condition and ability to commercialize products[189]. Clinical Trials and Development - The clinical development process is lengthy and costly, with inherent uncertainties regarding the effectiveness and safety of candidate products[193]. - The company may face delays or inability to obtain regulatory approvals for candidate products, limiting the realization of their full potential[178]. Risk Management - The company conducts annual enterprise risk assessments to identify top risks and develop risk management strategies based on these assessments[110]. - The risk coordination committee provides a forum for discussing, identifying, monitoring, and managing risks across the organization[111]. Insurance and Liability - The company has purchased necessary insurance policies to cover various operational risks, including liability insurance for clinical trials and product liability insurance[108]. Economic and Political Environment - The company's operations are significantly influenced by the economic, political, and social conditions in mainland China, which differ from those in the U.S.[134]. - The company may face challenges in receiving foreign investment approvals from Chinese regulatory bodies, which could delay or prevent transactions[120].

Group 1 - The core viewpoint of the article highlights the performance of the CSI Hong Kong Stock Connect Innovative Drug Index, which rose by 0.8% to 743.38 points, with a trading volume of 12.742 billion yuan [1] - The index has experienced a decline of 1.19% over the past month, but has increased by 28.61% over the last three months and by 26.81% year-to-date [1] - The index comprises 50 listed companies involved in innovative drug research and development, reflecting the overall performance of innovative drug companies within the Hong Kong Stock Connect framework [1] Group 2 - The top ten weighted companies in the index include Innovent Biologics (11.68%), WuXi Biologics (10.35%), BeiGene (10.3%), CanSino Biologics (9.55%), CSPC Pharmaceutical Group (7.56%), China Biologic Products (6.68%), Hansoh Pharmaceutical (4.26%), Zai Lab (4.07%), 3SBio (3.58%), and WuXi AppTec (3.58%) [1] - The index's holdings are entirely composed of companies listed on the Hong Kong Stock Exchange, with a sector breakdown showing that biopharmaceuticals account for 48.63%, chemical drugs for 29.62%, pharmaceutical and biotechnology services for 20.56%, and medical commerce and services for 1.19% [2] - The index samples are adjusted biannually, with changes implemented on the next trading day following the second Friday of June and December each year, ensuring that the weight factors are updated accordingly [2]

Investment Rating - The report maintains a "Buy" rating for Zai Lab (ZLAB) with a 12-month price target of $53.91, indicating an upside potential of 82.5% from the current price of $29.54 [10][11]. Core Insights - The competitive landscape for generalized Myasthenia Gravis (gMG) treatment is evolving, particularly with the positive Phase 3 results of telitacicept, which has implications for Zai Lab's efgartigimod [1]. - Efgar's competitive profile is highlighted by its quick treatment onset and durable symptom improvement, making it a favorable option for refractory gMG patients [1][4]. - Zai Lab is transitioning from a licensing-in model focused on China to a dual engine model that includes in-house development and global opportunities, which is expected to enhance its R&D progress [9]. Summary by Sections Competitive Landscape - The report discusses the competitive dynamics in gMG treatment, noting that while telitacicept shows deep patient response, efgar demonstrates quicker symptom relief, which is crucial for patient adoption [4][8]. - The treatment duration is a significant differentiator, with efgar accumulating clinical evidence for long-term usage, while RC18 is positioned as a long-term maintenance therapy [4][5]. Clinical Data Comparison - Efgar shows a mean change of -5.13 in MG-ADL score at week 21, compared to RC18's -5.74 at week 24, indicating efgar's quicker onset of symptom improvement [9]. - The report emphasizes the variability in placebo profiles across clinical trials, suggesting caution in cross-trial comparisons [8]. Market Position and Future Outlook - Zai Lab's efgar is positioned favorably due to its two-year lead in NRDL coverage and endorsements from clinical guidelines in both China and the US [8]. - The report anticipates that Zai Lab's global pipeline will attract more market interest starting in 2025, as the company becomes more selective in its licensing deals [9].

Core Viewpoint - CICC maintains its earnings forecast for Zai Ding Pharmaceutical (09688) for 2025 and 2026, with a target price of HKD 34.41/USD 44.24 based on DCF model, and continues to rate it as outperforming the industry [1] Group 1: Product Approval and Administration - The FDA has approved the subcutaneous pre-filled injection of Efgartigimod, which can be administered by patients, caregivers, or healthcare professionals, taking 20-30 seconds per injection [2] - Efgartigimod's approval is based on its bioequivalence to the vial formulation, and the company plans to submit a domestic application for the pre-filled injection by 2025 [2] Group 2: Efgartigimod's Efficacy - Efgartigimod is considered the best therapy for gMG, with a cumulative achievement rate of 40%-73% for minimal symptom expression (MG-ADL ≤ 1), significantly outperforming competitors [3] - The drug shows rapid onset of action, with significant improvement in ADL within the first week and a 73.0% improvement by week four [3] - Long-term efficacy is supported by a three-year follow-up study (ADAPT+), demonstrating sustained effectiveness with a controlled infection risk and a serious adverse event rate of 4.8% [3] Group 3: Upcoming Catalysts and Product Developments - The company has a rich pipeline with several key products expected to report critical data, including ZL-1310 (DLL3 ADC) with positive ORR data expected in 1H25 [4] - Bemarituzumab (FGFR2b) is anticipated to report clinical data from the global Phase III FORTITUDE-101 study in 1H25, followed by a domestic NDA submission [4] - KarXT has received FDA approval, with its domestic application accepted in January 2025, and results for the global Phase III data for ADP are expected in 2H25 [4] - The company plans to submit domestic applications for tumor electric field therapy for pancreatic cancer and non-small cell lung cancer by 2025 [4]

Core Insights - The recent AAN annual meeting showcased significant advancements in the treatment of Myasthenia Gravis (MG), particularly with new targeted biologics entering the market, indicating a shift in the competitive landscape for MG therapies [1] Competitive Landscape in gMG Treatment - The report from Goldman Sachs highlights the positive clinical data from Rongchang Biopharma's dual-target biologic RC18, which has shown deep patient response capabilities, sparking discussions on its efficacy compared to FcRn antagonists like Efgartigimod [2] - FcRn class drugs, including Efgartigimod, are expected to have a speed advantage in onset of action due to their mechanism of action, which could provide a competitive edge in the market [2] - Efgartigimod demonstrated a 4.6-point reduction in MG-ADL scores by week 4, more than double the efficacy of RC18 at the same time point, highlighting the importance of rapid onset in treating acute and refractory patients [2] Maintenance Therapy as a Future Focus - As MG is a chronic disease requiring long-term management, maintenance therapy is anticipated to become a key competitive focus in the MG drug market [4] - Efgartigimod currently employs an intermittent treatment model of "4 weeks on + 3 weeks off," but is exploring a more flexible bi-weekly maintenance treatment option, showing good safety and sustained efficacy in clinical data [4] External Factors Influencing Competition - The report emphasizes that factors beyond clinical data, such as insurance coverage, will significantly impact the competitive landscape for gMG treatments [5] - Efgartigimod has been included in China's National Reimbursement Drug List (NRDL) since 2023, while RC18 is not expected to gain reimbursement coverage until 2026, providing Efgartigimod with at least a two-year market lead [5] Administration Method Diversity - Efgartigimod's recently FDA-approved pre-filled subcutaneous injection allows for self-administration, enhancing convenience for patients, while RC18 is limited to subcutaneous injection [7] - Efgartigimod is widely recommended in treatment guidelines in both the US and China, enhancing its brand value and trust among healthcare providers and patients [7] Overall Competitive Advantage - Despite RC18's strong efficacy, Efgartigimod's rapid onset, flexible treatment options, and market lead position it favorably in the gMG treatment landscape [7]

Investment Rating - The report maintains a "Buy" rating for Zai Lab (09688.HK) [2] Core Views - Zai Lab's drug Efgartigimod shows strong potential in the treatment of Myasthenia Gravis (MG) with rapid onset and long-term efficacy, establishing its position as a Best-in-Class (BIC) therapy [8][11] - The FDA has approved the pre-filled subcutaneous injection form of Efgartigimod, enhancing its competitive edge in the market [25][26] - The company is expected to achieve significant revenue growth, with projected revenues of $564 million in 2025 and $1.357 billion in 2027, reflecting growth rates of 41.35% and 62.46% respectively [7][40] Summary by Sections Market Performance - Zai Lab's stock price is currently at HKD 22.20, with a market capitalization of HKD 24.45 billion [2][7] Financial Data and Forecast - Total shares outstanding: 1,101.28 million - Revenue projections: $267 million in 2023, $399 million in 2024, $564 million in 2025, $835 million in 2026, and $1.357 billion in 2027 - Net profit projections: -$335 million in 2023, -$257 million in 2024, -$166 million in 2025, $17 million in 2026, and $168 million in 2027 - Gross margin expected to improve from 62.94% in 2024 to 69.45% in 2027 [7][40] Drug Development Insights - Efgartigimod has shown rapid efficacy in clinical trials, with 40% of patients achieving minimal symptom expression (MSE) within the first treatment cycle [8][14] - Long-term studies indicate consistent efficacy and safety, with 89% of patients showing significant improvement after 11 treatment cycles [21][22] - The drug is positioned to treat multiple autoimmune diseases, expanding its market potential beyond MG [37][32] Competitive Landscape - Despite the emergence of several competing biologics in the MG treatment space, Efgartigimod's sales growth remains robust, with projected global sales of approximately $2.2 billion in 2024 [32][34]

[Table_Main] 证券研究报告 | 公司点评 再鼎医药(09688.HK) 2025 年 04 月 14 日 买入（维持） 所属行业：医疗保健业/药品及生物科技 当前价格(港币)：22.20 元 证券分析师 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -31% 0% 31% 63% 94% 126% 157% 188% 2024-04 2024-08 2024-12 再鼎医药 恒生指数 | 恒 生 指 数 对 | 1M | 2M | 3M | | --- | --- | --- | --- | | 比 | | | | | 绝对涨幅(%) | -18.83 | 5.21 | 17.34 | | 相对涨幅(%) | -7.45 | 9.53 | 7.63 | | 资料来源：德邦研究所，聚源数据 | | | | 重症肌无力领域近期新药进展众多，我们认为艾加莫德作为 BIC，在 MG 治疗领 域地位难以被撼动。 1）快速起效，快速达标：越来越多的临床试验使用基 ...

相关ETF方面，截至发稿，港股创新药ETF（159567）高开高走，现涨5%。成分股中，再鼎医药涨超 14%，药明合联、科伦博泰生物-B、东阳光长江药业、荣昌生物等涨幅居前。 4月14日，港股集体高开，创新药板块涨幅居前。 消息面上，Wind金融终端数据显示，截至4月13日，已有超过230家生物医药行业上市公司披露了2024 年度经营数据（含年报、业绩快报）。其中，25家公司营收突破百亿元大关，上海医药以2752.51亿元 的营收一骑绝尘；有近半数企业盈利能力持续上升，26家公司归母净利润超过10亿元，药明康德以94.5 亿元的归母净利润领跑行业；超过半数的企业研发投入持续增长，其中百济神州全年研发费用高达 19.53亿美元（约合人民币142.79亿元），同比增长9.8%，占营收比例约为52%。 广发证券表示，建议重视港股创新药的配置价值，原因在于：首先，中国创新药出海的全球竞争优势正 在凸显。近年来，中国药企在海外市场的License-out交易实现了跨越式发展，展现出中国创新药研发的 全球竞争力。NewCo模式的兴起，进一步为原药企解决了融资难、变现难、研发风险大等问题。其 次，当前关税政策对创新药影响远 ...

截至2025年4月14日 09:43，恒生医疗保健指数(HSHCI)强势上涨2.95%，成分股再鼎医药(09688)上涨12.39%，东阳光长江药业(01558)上涨9.04%，科伦博泰 生物-B(06990)上涨6.69%，百济神州(06160)，云顶新耀-B(01952)等个股跟涨。恒生医疗ETF(513060)上涨3.15%， 冲击4连涨。最新价报0.46元。拉长时间 看，截至2025年4月11日，恒生医疗ETF近3月累计上涨21.98%。 流动性方面，恒生医疗ETF盘中换手3.65%，成交4.42亿元。拉长时间看，截至4月11日，恒生医疗ETF近1周日均成交24.90亿元，排名可比基金第一。 规模方面，恒生医疗ETF近1周规模增长12.54亿元，实现显著增长，新增规模位居可比基金1/3。 数据显示，杠杆资金持续布局中。恒生医疗ETF最新融资买入额达3.26亿元，最新融资余额达5.03亿元。 截至4月11日，恒生医疗ETF近1年净值上涨26.66%。从收益能力看，截至2025年4月11日，恒生医疗ETF自成立以来，最高单月回报为28.34%，最长连涨月 数为4个月，最长连涨涨幅为38.75%，上涨月份平 ...

智通财经4月14日电，截至发稿，再鼎医药(09688.HK)涨13.51%、来凯医药-B(02105.HK)涨10.34%、基 石药业-B(02616.HK)涨6.28%、腾盛博药-B(02137.HK)涨6.17%、药明合联(02268.HK)涨5.94%。 港股医药股多数走强 再鼎医药涨超13% ...